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Completed

NCT Number: NCT01069731

Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants

This is a research study to quantitatively assess the development of non-nutritive suck (NNS) and feeding readiness in preterm infants using a novel device, the NTrainer©, and to compare this with two clinical assessment tools, NOMAS and EFS.

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Key information

Age range

30 week–36 week

Sex eligibility

All sexes

Study type

Observational

Primary location

WakeMed

Raleigh, North Carolina, 27610, United States

About this study

Fifteen minutes before feeding, the mobile NTrainer recording station will be positioned cribside. Following a brief exam of physiologic state, using the Oral Feeding Readiness Assessment portion of the EFS, the infant will be cradled in a supportive inclined posture, swaddled, with limbs positioned at midline, and background/overhead lighting dimmed in the area to promote eye contact with the tester. Sampling of NNS behavior will not be initiated until the infant is in an optimal behavioral state, i.e., drowsy to active alert (state 3 or 4 or 5 as described by the Naturalistic Observation of Newborn Behavior, Newborn Individualized Developmental Care and Assessment Program; NIDCAP). The infant will be presented with the NTrainer pacifier, and several contiguous 30-second blocks of NNS nipple compression data will be sampled using the NeoSuck RT software. The infant will remain connected to the usual NICU monitors at all times for observation of respiration, heartbeat and oxygen saturation.

After the NTrainer data collection is completed, the baby will be fed by his or her nurse or parents as directed in the care plan. If the baby is able to feed by mouth, one of the investigators will observe the feeding, and perform 1) a NOMAS evaluation during the first 2 minutes of the feeding, and 2) an EFS assessment after the feeding is completed.

Infants will be studied in 2 sessions each day beginning at Day 4 to 7 of life, then twice weekly (2 sessions per day, 2 days per week) until hospital discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born at 30 to 36 weeks gestation and have no exclusion criteria.

Exclusion criteria

  • Significant birth defects.
  • Breathing difficulties severe enough to require being on a ventilator or nasal CPAP for more than 2 hours after birth.
  • Any oxygen requirement at Day 4 of life.
  • Any neurologic problems, including seizures or frequent apnea spells.

Treatment and study plan

Primary outcomes

  1. To describe NNS pressure waveforms and NNS-STI values in normal premature infants with gestational ages 30 to 36 weeks during the first week of life.

    Time frame: First Weeks of Life

Secondary outcomes

  1. To describe the progression of NNS waveform pattern and NNS-STI values in normal premature infants as they mature to term postmenstrual age.

    Time frame: Mature to full term postmenstrual age

Sponsors and collaborators

Lead sponsor

KC BioMediX, Inc

Industry

Registry information

Official study title

Comparison of NNS Performance Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants Using the NTrainer Device

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 17, 2010
Registry last updated
Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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